Proven efficacy in patients with advanced cutaneous squamous cell carcinoma (CSCC)1

Response rates in patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation (N = 137), based on efficacy results for Study 1540: 3 mg/kg every 2 weeks1

  • aMedian duration of follow-up was 11.1 months for combined CSCC in Study 1540.1 See additional study design details.1
  • bPartial response is defined as a decrease of 30% or greater in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. Partial response of externally visible disease is defined as a decrease of 50% or greater in the sum of products of perpendicular longest diameters of target lesions, per WHO Criteria. Nontarget lesions could not have progressive disease, and there could be no new lesions. Responses had to be maintained for at least 4 weeks.2
  • cComplete response is defined as disappearance of all target lesions for at least 4 weeks. Nontarget lesions also had to be a complete response, and there could be no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; laCSCC patients in Study 1540 required biopsy to confirm CR.1,2

  • CI, Confidence Interval; RECIST, Response Evaluation Criteria in Solid Tumors; WHO, World Health Organization.

Considerable tumor reduction with LIBTAYO1

Tumor responses demonstrated with LIBTAYO in patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation, based on efficacy results for Study 1540: 3 mg/kg every 2 weeks1,a

Efficacy endpoints Metastatic CSCC
(n = 59), %
Locally advanced CSCC
(n = 78), %
Combined CSCC
(N = 137), %
Complete response, CR 17 13 15
Partial response, PR 32 31 31
Objective response rate,
ORR (CR + PR)
49 44 46
  • aMedian duration of follow-up: mCSCC: 16.5 months; laCSCC: 9.3 months; combined CSCC: 11.1 months.1

In an additional cohort in Study 1540, 56 mCSCC patients received LIBTAYO at a dose of 350 mg intravenously every 3 weeks for up to 54 weeks. With a median duration of follow-up of 8.0 months, the confirmed ORR was 41% (95% CI: 28, 55), and 65% of responders had a DOR ≥6 months.1

Among 26 CSCC patients in Study 1423, 16 had mCSCC and 10 had laCSCC. One patient in the mCSCC group was dosed at 1 mg/kg every 2 weeks. The rest received 3 mg/kg every 2 weeks. With a median duration of follow-up of 13.3 months, the confirmed ORR was 50% (95% CI: 30, 70); all responses were PRs. The median time to response was 1.9 months (range: 1.7‐7.3 months), and 85% of responders had a DOR ≥6 months.1

The data cutoffs for the above results were September/October 2018 for Study 1540 and June 2018 for Study 1423.

laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; Q2W, every 2 weeks; Q3W, every 3 weeks.

The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.1

NCCN preferred Category 2A Option for Advanced CSCC
NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®)

Category 2A* (Preferred) Recommended Systemic Therapy Option for Patients With Advanced Cutaneous Squamous Cell Carcinoma If Curative Surgery and Curative Radiation Therapy Are Not Feasible3

NCCN Guidelines® recommend cemiplimab-rwlc (LIBTAYO), an immune checkpoint inhibitor, as a preferred systemic therapy option for appropriate patients with3:

  • Locally advanced or regional CSCC when curative surgery and curative radiation therapy are not feasible
  • Distant metastatic or regionally recurrent CSCC when curative surgery and curative radiation therapy are not feasible
*Category 2A recommendation is based upon lower-level evidence; there is uniform NCCN consensus that the intervention is appropriate. All recommendations are Category 2A unless otherwise specified.

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. To view the most recent and complete version of the guidelines, go online to NCCN.org.

Indication and Usage

LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
  2. Data on file. Regeneron Pharmaceuticals, Inc.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Squamous Cell Skin Cancer V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. To view the most recent and complete version of the guidelines, go online to NCCN.org.